Application for conformity assessment certificates (medical devices)

16 September 2013

Guidance on how to apply for a conformity assessment certificate can be found in the document 'Application Instructions' below and in the Australian Regulatory Guidelines for Medical Devices (ARGMD) part 1 section 1 'Process to supply a medical device in Australia'.

As part of the conformity assessment application process, the manufacturer of a medical device is required to provide the 'Supporting data form' together with the supporting data of an application. The applicant should use either the single word version of the form OR the PDF version of the form with additional form pages as required.

Guidance

How to access a pdf or Word document

This document provides guidance on how to apply for a conformity assessment certificate.

Forms

Conformity assessment certification - supporting data form

Additional pages

Note: The 'supporting data form' must only be provided to the TGA with the supporting data of the application after the applicant receives the acknowledgment email from the TGA for the lodged application in eBusinessServices. Only current forms will be accepted. Additional pages (e.g., for several facilities, devices, etc.) can be used as required.

Additional section 3.3: Manufacturer facility (site) details

Additional section 4: Critical supplier's details

Additional section 5: Device details - non-IVD devices only

Additional section 6: IVD device details

Additional attachment 1 - New certificate checklist

Additional attachment 2 - Substantial change checklist

Additional attachment 3 - Recertification checklist